Protocol for the Femoroacetabular Impingement Trial (FAIT): a multi-centre randomised controlled trial comparing surgical and non-surgical management of femoroacetabular impingement

A J R Palmer, V Ayyar-Gupta, S J Dutton, I Rombach, C D Cooper, T C Pollard, D Hollinghurst, A Taylor, K L Barker, E G McNally, D J Beard, A J Andrade, A J Carr, S Glyn-Jones, A J R Palmer, V Ayyar-Gupta, S J Dutton, I Rombach, C D Cooper, T C Pollard, D Hollinghurst, A Taylor, K L Barker, E G McNally, D J Beard, A J Andrade, A J Carr, S Glyn-Jones

Abstract

Aims: Femoroacetabular Junction Impingement (FAI) describes abnormalities in the shape of the femoral head-neck junction, or abnormalities in the orientation of the acetabulum. In the short term, FAI can give rise to pain and disability, and in the long-term it significantly increases the risk of developing osteoarthritis. The Femoroacetabular Impingement Trial (FAIT) aims to determine whether operative or non-operative intervention is more effective at improving symptoms and preventing the development and progression of osteoarthritis.

Methods: FAIT is a multicentre superiority parallel two-arm randomised controlled trial comparing physiotherapy and activity modification with arthroscopic surgery for the treatment of symptomatic FAI. Patients aged 18 to 60 with clinical and radiological evidence of FAI are eligible. Principal exclusion criteria include previous surgery to the index hip, established osteoarthritis (Kellgren-Lawrence ≥ 2), hip dysplasia (centre-edge angle < 20°), and completion of a physiotherapy programme targeting FAI within the previous 12 months. Recruitment will take place over 24 months and 120 patients will be randomised in a 1:1 ratio and followed up for three years. The two primary outcome measures are change in hip outcome score eight months post-randomisation (approximately six-months post-intervention initiation) and change in radiographic minimum joint space width 38 months post-randomisation. ClinicalTrials.gov: NCT01893034. Cite this article: Bone Joint Res 2014;3:321-7.

Keywords: Femoroacetabular Impingment; Hip Arthroscopy; Osteoarthritis; Physiotherapy; Randomised Controlled Trial.

Conflict of interest statement

ICMJE Conflict of Interest:None declared.

©2014 The British Editorial Society of Bone & Joint Surgery.

Figures

Fig. 1
Fig. 1
Femoroacetabular Impingement Trial (FAIT) flowchart.

References

    1. Ganz R, Parvizi J, Beck M, et al. Femoroacetabular impingement: a cause for osteoarthritis of the hip. Clin Orthop Relat Res 2003;417:112–120.
    1. Laborie LB, Lehmann TG, Engesæter IØ, et al. Prevalence of radiographic findings thought to be associated with femoroacetabular impingement in a population-based cohort of 2081 healthy young adults. Radiology 2011;260:494–502.
    1. Agricola R, Waarsing JH, Arden NK. , et al. Cam impingement of the hip: a risk factor for hip osteoarthritis. Nat Rev Rheumatol 2013;9:630–634.
    1. Khanna V, Caragianis A, Diprimio G, Rakhra K, Beaulé PE. Incidence of hip pain in a prospective cohort of asymptomatic volunteers: is the cam deformity a risk factor for hip pain? Am J Sports Med 2014;42:793–797.
    1. Agricola R, Heijboer MP, Bierma-Zeinstra SM, et al. Cam impingement causes osteoarthritis of the hip: a nationwide prospective cohort study (CHECK). Ann Rheum Dis 2013;72:918–923.
    1. Nicholls AS, Kiran A, Pollard TC, et al. The association between hip morphology parameters and nineteen-year risk of end-stage osteoarthritis of the hip: a nested case-control study. Arthritis Rheum 2011;63:3392–3400.
    1. Clohisy JC, Dobson MA, Robison JF, et al. Radiographic structural abnormalities associated with premature, natural hip-joint failure. J Bone Joint Surg [Am] 2011;93-A(Suppl 2):3–9.
    1. Palmer AJ, Thomas GE, Pollard TC, et al. The feasibility of performing a randomised controlled trial for femoroacetabular impingement surgery. Bone Joint Res 2013;2:33–40.
    1. Wall PD, Fernandez M, Griffin DR, Foster NE. Nonoperative treatment for femoroacetabular impingement: a systematic review of the literature. PM R 2013;5:418–426.
    1. Bedi A, Chen N, Robertson W, Kelly BT. The management of labral tears and femoroacetabular impingement of the hip in the young, active patient. Arthroscopy 2008;24:1135–1145.
    1. Ng VY, Arora N, Best TM, Pan X, Ellis TJ. Efficacy of surgery for femoroacetabular impingement: a systematic review. Am J Sports Med 2010;38:2337–2345.
    1. Clohisy JC, St John LC, Schutz AL. Surgical treatment of femoroacetabular impingement: a systematic review of the literature. Clin Orthop Relat Res 2010;468:555–564.
    1. Gedouin JE, May O, Bonin N, et al. Assessment of arthroscopic management of femoroacetabular impingement. A prospective multicenter study. Orthop Traumatol Surg Res 2010;96(8 Suppl):S59–S67.
    1. Philippon MJ, Briggs KK, Yen YM, Kuppersmith DA. Outcomes following hip arthroscopy for femoroacetabular impingement with associated chondrolabral dysfunction: minimum two-year follow-up. J Bone Joint Surg [Br] 2009;91-B:16–23.
    1. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–207.
    1. Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis 1957;16:494–502.
    1. Conaghan PG, Hunter DJ, Maillefert JF, Reichmann WM, Losina E. Summary and recommendations of the OARSI FDA osteoarthritis Assessment of Structural Change Working Group. Osteoarthritis Cartilage 2011;19:606–610.
    1. Palmer A, Thomas G, Whitwell D, et al. Temporal Trends in Arthroscopy and Joint Preserving Surgery of the Hip from 2001 to 2010: A Study of 12,684 Procedures using the HES Database. Bone Joint J 2013;95-B(Supp 1):96.
    1. Matsuda DK, Carlisle JC, Arthurs SC, Wierks CH, Philippon MJ. Comparative systematic review of the open dislocation, mini-open, and arthroscopic surgeries for femoroacetabular impingement. Arthroscopy 2011;27:252–269.
    1. Papavasiliou A, Bardakos NV. Complications of arthroscopic surgery of the hip. Bone Joint Res 2012;1:131–144.
    1. Ayeni OR, Belzile EL, Musahl V, et al. Results of the PeRception of femOroaCetabular impingEment by Surgeons Survey (PROCESS). Knee Surg Sports Traumatol Arthrosc 2014;22:906–910.
    1. Martin RL. Hip Arthroscopy and Outcome Assessment. Operative Techniques in Orthopaedics 2005;15:290–296.
    1. Martin RL, Philippon MJ. Evidence of reliability and responsiveness for the hip outcome score. Arthroscopy 2008;24:676–682.
    1. Krych AJ, Thompson M, Knutson Z, Scoon J, Coleman SH. Arthroscopic labral repair versus selective labral debridement in female patients with femoroacetabular impingement: a prospective randomized study. Arthroscopy 2013;29:46–53.
    1. Schenker ML, Martin R, Weiland DE, Philippon MJ. Current trends in hip arthroscopy: a review of injury diagnosis, techniques, and outcome scoring. Curr Op Orthop 2005;16:89–94.
    1. Domb BG, Stake CE, Botser IB, Jackson TJ. Surgical dislocation of the hip versus arthroscopic treatment of femoroacetabular impingement: a prospective matched-pair study with average 2-year follow-up. Arthroscopy 2013;29:1506–1513.
    1. Reichmann WM, Maillefert JF, Hunter DJ, et al. Responsiveness to change and reliability of measurement of radiographic joint space width in osteoarthritis of the knee: a systematic review. Osteoarthritis Cartilage 2011;19:550–556.
    1. Altman RD, Bloch DA, Dougados M, et al. Measurement of structural progression in osteoarthritis of the hip: the Barcelona consensus group. Osteoarthritis Cartilage 2004;12:515–524.
    1. Thorborg K, Roos EM, Bartels EM, Petersen J, Hölmich P. Validity, reliability and responsiveness of patient-reported outcome questionnaires when assessing hip and groin disability: a systematic review. Br J Sports Med 2010;44:1186–1196.
    1. Christensen CP, Althausen PL, Mittleman MA, Lee JA, McCarthy JC. The nonarthritic hip score: reliable and validated. Clin Orthop Relat Res 2003;406:75–83.
    1. Mohtadi NG, Griffin DR, Pedersen ME, et al. The development and validation of a self-administered quality-of-life outcome measure for young, active patients with symptomatic hip disease: the International Hip Outcome Tool (iHOT-33). Arthroscopy 2012;28:595–605.
    1. Thorborg K, Hölmich P, Christensen R, Petersen J, Roos EM. The Copenhagen Hip and Groin Outcome Score (HAGOS): development and validation according to the COSMIN checklist. Br J Sports Med 2011;45:478–491.
    1. Dawson J, Fitzpatrick R, Carr A, Murray D. Questionnaire on the perceptions of patients about total hip replacement. J Bone Joint Surg [Br] 1996;78-B:185–190.
    1. Freynhagen R, Baron R, Gockel U, Tölle TR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin 2006;22:1911–1920.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983;67:361–370.
    1. Jaremko JL, Lambert RG, Zubler V, et al. Methodologies for semiquantitative evaluation of hip osteoarthritis by magnetic resonance imaging: approaches based on the whole organ and focused on active lesions. J Rheumatol 2014;41:359–369.
    1. EuroQol Group. EuroQol: a new facility for the measurement of health-related quality of life Health Policy 1990;16:199–208.
    1. Palmer AJ, Brown CP, McNally EG, et al. Non-invasive imaging of cartilage in early osteoarthritis. Bone Joint J 2013;95-B:738–746.
    1. Lotz M, Martel-Pelletier J, Christiansen C, et al. Value of biomarkers in osteoarthritis: current status and perspectives. Ann Rheum Dis 2013;72:1756–1763.
    1. Allen KD. The value of measuring variability in osteoarthritis pain. J Rheumatol 2007;34:2132–2133.
    1. Egerton T, Hinman RS, Takla A, Bennell KL, O'Donnell J. Intraoperative cartilage degeneration predicts outcome 12 months after hip arthroscopy. Clin Orthop Relat Res 2013;471:593–599.
    1. Sipola P, Niemitukia LH, Hyttinen MM, Arokoski JP. Sample size for prospective studies of hip joint space width narrowing in osteoarthritis by the use of radiographs. Skeletal Radiol 2011;40:431–438.
    1. Maheu E, Cadet C, Marty M, et al. Reproducibility and sensitivity to change of various methods to measure joint space width in osteoarthritis of the hip: a double reading of three different radiographic views taken with a three-year interval. Arthritis Res Ther 2005;7:R1375–R1385.

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